Circulating Tumor DNA Exposure in Peripheral Blood

Quantgene

Status: Unknown

Conditions: Breast Cancer; Melanoma; Bladder Cancer; Gastric Cancer; Non-small Cell Lung Cancer; Pancreatic Adenocarcinoma; Other Cancer; Hepatocellular Carcinoma; Adrenocortical Cancer; Ovarian Cancer; Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT03517332

QG01012015

Details and patient eligibility

About

This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).

Full description

This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• This study will include subjects that are diagnosed with a malignancy (cohort

  1. and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).

• Subjects of both cohorts must:

  • Be of age ≥ 18
  • Provide written consent for study participation

• Subject of cohort 1 must:

  • Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma

Subjects of cohort 2 must:

• Meet the listed matching criteria

Exclusion criteria

• Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy

• Subjects of cohort 2 must not:

  • Have been diagnosed/treated for a malignancy previously

Trial design

10,000 participants in 2 patient groups

Cohort 1

Description:

Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma Subjects of cohort 1 must not: • Have been treated for above diagnosed malignancy

Cohort 2

Description:

Negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2). Subjects of cohort 2 must: • Meet the listed matching criteria Subjects of cohort 2 must not: • Have been diagnosed/treated for a malignancy previously